FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Tablet Application
K Number: K203566
·
Decision May 13, 2021
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
17
Applicant Total
16
Review Days
157
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Basic Information
- Device Name
- Tablet Application
- K Number
- K203566
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smith & Nephew
- Date Received
- December 7, 2020
- Decision Date
- May 13, 2021
- Product Code
- ODA
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ODA | Endoscopic Central Control Unit | FDA class 2 | Gastroenterology, Urology |
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| K201198 | S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable | Jul 17, 2020 | Substantially Equivalent |
| K192876 | INTELLIO Tablet Application | Feb 27, 2020 | Substantially Equivalent |
| K190367 | Smith & Nephew Tablet Application | May 21, 2019 | Substantially Equivalent |